FaceScan for Measuring Visual Acuity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, unable to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called FaceScan to evaluate its accuracy in measuring vision compared to standard eye tests. It also seeks to develop a system that recognizes spoken letters by collecting voice recordings. Adults visiting the Ophthalmology Clinic who can provide consent are ideal candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve future eye care technologies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the FaceScan device is safe for measuring visual acuity?

Research has shown that FaceScan, a digital tool for assessing vision, is designed to be safe and effective. The FDA classifies it as a system for testing vision, indicating its use in evaluating eyesight.

While specific safety details from studies aren't provided, ongoing research for accuracy and validation suggests general acceptance of FaceScan. The trial is in a "Not Applicable" phase, focusing on confirming the device's functionality rather than testing its safety on people, indicating that safety isn't a major concern at this stage.

Overall, FaceScan appears to be a promising tool for checking vision, with no specific reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FaceScan technique for measuring visual acuity because it represents a new, digital approach to eye exams. Unlike traditional methods that rely on manual, chart-based tests, FaceScan uses advanced technology to deliver a digital visual acuity test. This method could potentially offer more precise and objective measurements, reducing human error. Plus, the convenience of a digital format may streamline the exam process, making it quicker and more accessible for both patients and healthcare providers.

What evidence suggests that the FaceScan device is effective for measuring visual acuity?

Research has shown that digital tools for assessing vision can be as accurate as traditional methods. Studies indicate that patients can even use these digital tools independently at home. In this trial, the FaceScan device aims to measure vision clarity by comparing its results to standard tests. Although specific data on FaceScan remains limited, the overall success of digital vision tests suggests it could perform effectively. Early results from similar technologies indicate reliable performance, making FaceScan a promising tool for vision assessment. ^{1 3 6 7 8}

Who Is on the Research Team?

Antonio Forte, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who visit the Ophthalmology Clinic and can give consent. It's not specified who cannot participate, so it seems open to all adult patients needing visual acuity measurements.

Inclusion Criteria

Willing and able to provide consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline ophthalmological examination including a digital visual acuity test with the FaceScan device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or issues post-assessment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• FaceScan

Trial Overview The study is testing a new digital device called FaceScan to check if it measures eyesight as well as standard methods. Participants will also help by providing voice recordings of letters for a speech recognition system.

How Is the Trial Designed?

Group I: Digital Visual Acuity Test Experimental Treatment 1 Intervention

Subjects for an ophthalmological examination that includes a visual acuity examination at Mayo Clinic in Florida have a digital visual acuity test conducted with the FaceScan device.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06431295

Evaluation of a Digital Visual Acuity Device vs. Standard ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. withpower.com withpower.com/trial/phase-visual-acuity-5-2024-c377e

FaceScan for Measuring Visual Acuity · Info for Participants The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual ...

3. ctv.veeva.com ctv.veeva.com/study/evaluation-of-a-digital-visual-acuity-device-vs-standard-visual-acuity-measurements

Evaluation of a Digital Visual Acuity Device vs. Standard ... The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8225487/

Digital Tools for the Self-Assessment of Visual Acuity This review gives a current overview of digital tools for remotely assessing visual function and reports on their accuracy.

5. formative.jmir.org formative.jmir.org/2023/1/e41045

The Accuracy of a Web-Based Visual Acuity Self-assessment ... This web-based test for measuring VA is a valid tool for remotely assessing VA, also when performed independently by patients at home.

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=QTO

Digital visual acuity testing - Product Classification - FDA A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients. Physical State, Digital Visual Acuity Testing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7809609/

Visual Acuity Testing for Telehealth Using Mobile ... This diagnostic study examines the accuracy and usability of visual acuity–testing apps available in the US Apple App Store.

8. recognito.vision recognito.vision/biometric-face-scanner-user-verification/

How Biometric Face Scanners Help Verify Users Accurately Learn how a biometric face scanner helps businesses verify users quickly, prevent fraud, and build trust through AI-powered facial ...